Data / Medical devices / Prosthesis, Hip, Femoral, Resurfacing
Prosthesis, Hip, Femoral, Resurfacing (KXA): 13 FDA-registered makers in 2 countries
13 establishments in 2 countries are registered with the FDA to make Prosthesis, Hip, Femoral, Resurfacing (product code KXA, Class 2, 21 CFR 888.3400). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on January 19, 2021, and lists 3 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- KXA
- Device class
- 2
- Regulation
- 888.3400
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Australia | 1 |
Makers of Prosthesis, Hip, Femoral, Resurfacing
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Microport Orthopedics Inc. | Arlington, TN, United States | Manufacturer | 3 | December 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| Signature Orthopaedics Pty Limited | Sydney New South Wales, Australia | Complaint file establishment, Manufacturer, Specification developer | 3 | June 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Arthrosurface, Inc. | W Bridgewater, MA, United States | Manufacturer | 1 | August 1, 2002 | 0 | 0 | 0 | api.fda.gov |
| Biocore9 LLC | Denville, NJ, United States | Manufacturer | 1 | January 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biopro, Inc. | Port Huron, MI, United States | Contract manufacturer, Manufacturer | 1 | May 18, 2005 | 0 | 0 | 0 | api.fda.gov |
| E. Bac Si Imports LLC | Ellensburg, WA, United States | Specification developer | 1 | May 23, 1991 | 0 | 0 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Manufacturer | 1 | April 13, 1995 | 0 | 2 | 0 | api.fda.gov |
| Aps Materials, Inc. | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Brimfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 19, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.